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510(k) Data Aggregation

    K Number
    K250734
    Device Name
    OptiLUV Device
    Manufacturer
    Pollogen Ltd.
    Date Cleared
    2025-09-10

    (183 days)

    Product Code
    PBX
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K140255,K181095
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OptiLUV device is a handheld device intended to emit energy in the RF spectrum to provide topical heating for the purpose of elevating facial tissue temperature for a temporary relief of minor pain and the temporary increase in local blood circulation.

    Device Description

    The OptiLUV device is a non-invasive, non-ablative device that delivers RF energy into the skin to generate heat through electrical impedance in the dermis. The device consists of the following components and accessories: the OptiLUV device, the USB Charging Cord, and the OptiLUV Preparation Balm.

    AI/ML Overview

    N/A

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